Passively activated safety needle assemblies and methods of use

ABSTRACT

Described are passively activated safety needle assemblies and methods for use. The assemblies comprise an elongate hollow outer shield, an elongate hub slidably engaged within the outer shield and biased to move proximally with respect to the outer shield. A locking ring in the hub has a ring element that cooperates with an activation element on the outer shield rotate the locking ring and disable the assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119(e) to Notice: Morethan one reissue application has been filed for the reissue of U.S. Pat.No. 9,186,466. The reissue applications are application Ser. No.15/814,493 (the present application), which is an application forreissue of U.S. Pat. No. 9,186,466 and a continuation of reissueapplication Ser. No. 15/812,245, which is also an application forreissue of U.S. Pat. No. 9,186,466. U.S. Pat. No. 9,186,466 claims thebenefit of U.S. Provisional Application No. 61/610,558, filed Mar. 14,2012, the disclosures disclosure of which are is incorporated herein byreference in their entirety.

TECHNICAL FIELD

The subject invention relates generally to a passively activated safetyneedle assemblies and methods for use. The assemblies comprise anelongate hollow outer shield, an elongate hub slidably engaged withinthe outer shield and biased to move proximally with respect to the outershield.

BACKGROUND

Embodiments of the invention generally relate to passively activatedsafety needle assemblies. More specifically, embodiments of theinvention are directed to passively activated safety needle assembliescomprising a locking ring and outer shield with cooperative structuresto disable the needle assemblies in a user safe manner.

Needle devices are used throughout the medical industry for theinjection and withdrawal of a wide variety of fluids and solutions intoand from the human body. Because of the numerous potential hazardsassociated with the handling and manipulation of bodily fluids, andparticularly blood, there are a number of known safety features that arefrequently incorporated into various types of needle devices to protectthe practitioner from accidental exposure to the needle.

Prior safety needle devices having a retractable sheath requiremulti-component retraction and locking elements and often do notincorporate reuse prevention features. Therefore, the retractionmechanism may be reset so the syringe barrel may be reused. The reuse ofsyringe assemblies without sterilization or sufficient sterilization isbelieved to facilitate the transfer of contagious diseases. Further, theretraction features of conventional syringes also often require the userto actively activate the retraction mechanism. Accordingly, the chanceof human error in failure to activate or properly activate theretraction mechanism can lead to continued exposure of needles

Prior retracting sheath safety needle devices have been developed toinclude a single-use cover assembly that obscures a substantial majorityor an entirety of an injection needle from view before, during, andafter an injection procedure. However, many injection procedures requirethat the practitioner see the needle and injection site or knowprecisely the depth to which the needle is inserted in the patient'stissue to be sure that medication is delivered to an appropriatelocation.

There is an ongoing need in the art for needles which passively activatea safety mechanism to prevent injury to the healthcare worker, orothers, and provide improved visibility of the needle.

SUMMARY

One or more embodiments of the invention are directed to passivelyactivated safety needle assemblies. The assemblies comprise an outershield, a hub and a locking ring. The outer shield is an elongate,hollow outer shield having a distal end, a proximal end, an outersurface and an inner surface. The outer shield includes an activationelement protruding inwardly from the inner surface. The outer shieldalso includes at least one finger biased radially inwardly. The hub isan elongate hub having a distal end and a proximal end. The hub isslidably engaged with the outer shield and biased to move in a proximaldirection. The hub includes a longitudinal groove that guides theactivation element during relative sliding motion between the hub andthe outer shield. The locking ring is on the hub and has a ring elementcomplementary to the activation element and at least one ramped surfaceradially spaced from the ring element. The ramped surface providing aproximal facing edge. Wherein, distal movement of the outer shield withrespect to the hub causes the activation element and ring element torotate the locking ring such that the at least one finger aligns withthe ramped surface. Subsequent proximal movement of the outer shieldcauses the at least one finger to engage the proximal facing edge,preventing further relative movement of the outer shield and hub.

In some embodiments, the hub includes a circumferential channel and thelocking ring is rotatably seated within the circumferential channel.

In one or more embodiments, the ring element is a substantiallytriangular wedge with a proximal end and a distal end, the proximal endbeing narrower than the distal end. In some embodiments, the activationelement is a substantially triangular wedge with a proximal end anddistal end, the proximal end being wider than the distal end. In one ormore embodiments, the activation element is a substantially triangularwedge with a proximal end and distal end narrower than the proximal endand the ring element if a complementary triangular wedge with a proximalend and distal end wider than the proximal end.

In some embodiments, there are two activation elements. In one or moreembodiments, the activation elements are positioned on opposite sides ofthe outer shield.

In some embodiments, there are two ring elements. In one or moreembodiments, the ring elements are on opposite sides of the lockingring.

In some embodiments, the locking ring further comprises a projectionextending one or more of proximally and distally from the locking ring.In one or more embodiments, the elongate hub further comprises at leastone complementary recess that engages the projection.

In some embodiments, the locking ring further comprises a longitudinalopening.

One or more embodiments further comprise a spring element positionedwithin the elongate, hollow outer shield adjacent the proximal end ofthe elongate hub. In some embodiments, the elongate, hollow outer shieldfurther comprises an aperture that permits a needle to extendtherethrough. Some embodiments further comprise a needle extending fromthe proximal end of the elongate hub within the spring element and theouter shield such that proximal movement of the hub with respect to theouter shield compresses the spring element and causes the needle toproject through the aperture. In some embodiments, the elongate hubfurther comprises a Luer connector on the distal end.

One or more embodiments further comprise a needle positioned within thehub so that distal movement of the outer shield with respect to the hubcompresses the spring element and causes the needle to extend from thedistal end of the hub. In some embodiments, the outer shield furthercomprises a Luer connector on the proximal end.

Additional embodiments of the invention are directed to passivelyactivated safety needle assemblies comprising a hub, a locking ring, anouter shield, a spring element and a needle. The hub has an elongatecylindrical body with an outer surface, an inner surface, a distal endand a proximal end defining a length, an aperture extending through thelength of the hub, at least two longitudinal grooves extending at leastpartially along the length of the hub and a circumferential channel. Thelocking ring has a cylindrical body rotatably positioned in thecircumferential channel of the hub and coaxial with the hub. The lockingring includes at least one ring element extending outwardly from anoutside surface of the locking ring. The at least one ring element has aproximal end, a distal end and a ramped face extending from the proximalend to the distal end. The locking ring has at least one ramp-shapedlocking tab extending outwardly from the outside surface of the ring.The at least one locking tab has a proximal locking face extending fromthe outside surface of the cylindrical body. The outer shield is coaxialto and slidable around the hub and locking ring. The outer shieldincludes an elongate hollow cylindrical body with an open distal end anda closed proximal end with an aperture to permit a needle to movetherethrough. The out shield includes at least one activation elementprojecting inwardly from an interior surface of the outer shield thatengages the at least one ring element. The at least one activationelement is sized to slidably move within a longitudinal groove on thehub and has a shape that cooperatively interacts with the at least onering element on the locking ring. The outer shield also has at least onefinger projecting inwardly and sized to slidably move within alongitudinal groove on the hub. The spring element is positionedadjacent the proximal end of the hub within the outer shield. The needleextends from the proximal end of the hub within the outer shield and thespring element. Wherein proximally directed force on the hub causescompression of the spring element, extends a tip of the needle throughthe aperture in the outer shield and causes the activation element toexert distally directed force onto the ring element to rotate thelocking ring such that the at least one finger on the outer shieldaligns with the at least one ramped surface.

In some embodiments, subsequent release of the proximally directed forceallows the spring element to expand causing distal movement of the hubwith respect to the outer shield so that the at least one finger slidesover the at least one ramped surface and that additional proximalmovement of the hub is prevented by interaction of the at least onefinger with the proximal locking face.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of a safety needle device in accordance withone or more embodiments of the invention;

FIG. 2 is a perspective view of a safety needle device with atransparent outer shield in accordance with one or more embodiments ofthe invention;

FIG. 3 is a perspective view of a safety needle device with an opaqueouter shield in accordance with one or more embodiments of theinvention;

FIG. 4 is a side view of a hub portion of a safety needle device inaccordance with one or more embodiments of the invention;

FIG. 5 is an end view of a hub portion of a safety needle device inaccordance with one or more embodiments of the invention;

FIG. 6 is a side view of a hub portion of a safety needle device inaccordance with one or more embodiments of the invention;

FIG. 7 is an isometric view of a locking ring in accordance with one ormore embodiments of the invention;

FIG. 8 is a top view of the locking ring of a safety needle device ofFIG. 7 in accordance with one or more embodiments of the invention;

FIG. 9 is a side view of a locking ring of a safety needle device inaccordance with one or more embodiments of the invention;

FIG. 10 is a side view of a locking ring of a safety needle device inaccordance with one or more embodiments of the invention;

FIG. 11 is a side view of a locking ring of a safety needle device inaccordance with one or more embodiments of the invention;

FIG. 12 is an isometric view of an opaque outer shield portion of asafety needle device in accordance with one or more embodiments of theinvention;

FIG. 13 is a side cross-sectional view of an outer shield portion of asafety needle device in accordance with one or more embodiments of theinvention;

FIG. 14 is a side cross-sectional view of an outer shield of a safetyneedle device in accordance with one or more embodiments of theinvention;

FIG. 15 is a perspective view of a safety needle device in an unlockedstate in accordance with one or more embodiments of the invention;

FIG. 16 is a perspective view of the safety needle device of FIG. 15 inthe process of locking in accordance with one or more embodiments of theinvention;

FIG. 17 is a perspective view of the safety needle device of FIG. 16 inthe process of locking in accordance with one or more embodiments of theinvention;

FIG. 18 is a perspective view of the safety needle device of FIG. 17 inthe locked state in accordance with one or more embodiments of theinvention;

FIG. 19. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention;

FIG. 20. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention;

FIG. 21. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention;

FIG. 22. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention;

FIG. 23. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention;

FIG. 24. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention; and

FIG. 25. shows the coordination of a locking ring and hub in accordancewith one or more embodiments of the invention.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

Embodiments of the invention comprise a design for a safety hypodermicneedle that allows health care workers to passively activate a safetymechanism during administration of hypodermic injections. As thehealthcare worker administers an injection using the described needles,a shield surrounding the needle is allowed to travel freely against theinjection site. As the needle is withdrawn from the patient, the shieldwill retract over the needle (supported by a material containing springlike material properties) and lock into place, providing protectionagainst needle stick injuries. This locking feature also prohibits there-use of the product for patient safety.

Embodiments of the device implement a ring-based component that tracksalong a needle hub to provide the dual states (i.e., locking andnon-locking) of the device.

Embodiments of the invention described are completely passive,needle-based, safety device. That is, that no extra action is requiredby the healthcare worker to activate the safety mechanism. Needle-basedsafety does not require a specialty syringe to activate the safetymechanism, allowing the device to be used on any standard Luer syringe.This benefit allows for higher adoption rates (as it can be applied inmore situations), lower cost (no specialty syringe), and greateraffordability. Passive safety may be seen as a benefit regarding theprevention of needle stick injuries. An additional benefit of therotating ring design, embodiments of the invention do not require theprotective shield to rotate to activate the safety mechanism (as thismight not always be possible, and thus prevent the activation of thesafety mechanism).

As described further below, some embodiments of the invention in the“inactivated” state comprise a standard Luer connecting hub and needleassembly, a clear outer shield, a snap-on ring and a spring element.Alternate embodiments of the invention include the reversal of thesecomponents; meaning, that the outer shield may contain the Luerconnection while the inner shield may serve as the injection site. Adevice in the “inactive” or “locked” state can be observed by theposition of the rotating ring. The rotating ring in some embodiments isa snap-on feature with an opening at one end. The ring can either befriction fit, preventing movement, or could contain one or more lockingfeatures to prevent premature movement of the ring prior to activation.In addition, though a 4-channel rotating ring design is shown in many ofthe drawings, multiple rings (or an alternate ring) can also beimplemented to achieve similar results.

The function of the safety mechanism is described with reference to theFigures below. Briefly, during the administration of medication, anactivation element on the outer shield mechanically forces the movementof a complimentary element on the rotating ring. Prior to theactivation, locking fingers are allowed to proceed unabated in the axialdirection. After injection is complete, the spring element forces theaxial movement of the outer shield to its original position. The springelement also contains enough energy to propel the locking finger overthe uniquely shaped feature on the locking ring, which serves to allowthe locking finger to pass over them but prevent their return. At thispoint, the injection has been given and the device is considered in the“locked” state.

FIGS. 1-3 show an embodiment of a passively activate safety needleassembly 100 in accordance with some aspects of the invention. Theassembly 100 comprises a hub 200, a locking ring 300 and an outer shield400. A spring element 500 and a needle element 600. FIG. 1 shows anexploded view of an embodiment of one or more embodiments of theinvention. FIG. 2 shows a view of the needle assembly of FIG. 1 in anassembled state with a transparent outer shield 400. FIG. 3 showsanother view of the needle assembly of FIG. 1 in an assembled state froma reverse angle to that of FIG. 2 with an opaque outer shield 400. Forease of describing the various features, aspects and embodiments, acommon numbering system is used throughout so similar features havesimilar numbers between Figures.

With reference to FIGS. 4 and 5, the hub 200 of one or more embodiments,comprises an elongate body 202 with a proximal end 204 and a distal end206 defining an overall length. FIG. 4 shows a side view of the hub 200and FIG. 5 shows an end view of the hub 200 looking at the distal end206. As will be described further below, the hub 200 is slidably engagedwith the outer shield 400 and the hub 200 is biased to move in aproximal direction relative to the outer shield 400.

The hub 200 of some embodiments includes at least one longitudinalgroove 208 which can be used to engage and guide one or more elements onthe outer shield 400 during relative sliding motion between the hub andthe outer shield, as will be described further. In FIG. 4, onelongitudinal groove is shown which can engage and guide one element fromthe outer shield. FIG. 5 shows an end view in which there are fourlongitudinal grooves 208 visible. Any or all of these longitudinalgrooves 208 can be used to guide elements from the outer shield 400.While hubs with one and four longitudinal grooves have been shown, itwill be understood by those skilled in the art that there can be anysuitable number of grooves depending on the number of elements from theouter shield, or other components, which need to be guided. As will beunderstood by those skilled in the art, guiding an element means thatthe element moves within the longitudinal groove and is substantiallyprevented from twisting circumferentially about the hub 200.

The shape of the hub 200 can be varied depending on the desired shapeof, for example, the outer shield 400. Here, the hub 200 is shown havinga roughly cylindrical shape which may be useful for engaging a roughlycylindrical outer shield. In some embodiments, the hub is an elongatetriangle (e.g., triangular prism), elongate tetrahedron, elongatepentahedron, elongate hexahedron, elongate heptahedron, elongateoctahedron, elongate nonahedron, elongate decahedron, etc. The shape ofthe outer shield 400 in some embodiments, substantially conforms to theshape of the hub 200. For example, if the hub 200 is generally anelongate octahedron, then the outer shield 400 would also be an elongateoctahedron roughly concentric to the hub 200. As used in thisspecification and the appended claims, the term “roughly cylindrical”means that the shape is a cylinder with grooves or channels as thatshown in FIG. 5.

The hub 200 of some embodiments has a circumferential channel 212extending about the circumference of the elongate body 202. The channel212 can be positioned anywhere along the length of the elongate body202. As shown in the Figures, the channel 212 is positioned nearer tothe proximal end 204 than the distal end 206. This is merely onepossible configuration and should not be taken as limiting the scope ofthe invention. In some embodiments, the circumferential channel 212 isnearer to the distal end 206 than the proximal end 204. In someembodiments, the channel 212 is immediately adjacent one of the proximalend 204 and distal end 206. In embodiments like that shown in FIG. 4,the circumferential channel 212 has a proximal end 214 and a distal end216. The distance between the proximal end 214 and distal end 216, whichcan also be referred to as the length of the circumferential channel212, can be any size as required. In some embodiments, thecircumferential channel 212 is about the same length as the locking ring300 so that the locking ring is friction fit within the channel 212 asdescribed further below.

The hub 200 shown in FIG. 4 has a single circumferential channel 212.This is merely illustrative and should not be taken as limiting thescope of the invention. In some embodiments, as shown in FIG. 6, the hub200 includes two or more circumferential channels 212, 212b. Any or allof the channels can be used in conjunction with one or more lockingrings and each of the channels can be the same length or differentlengths. The first channel 212 is closer to the proximal end 204 of theelongate body 202 and has a proximal end 214 and distal end 216, thedifference between defining a first channel length. The second channel212b is closer to the distal end 206 of the elongate body 202 and has aproximal end 214b and a distal end 216, the difference between defininga second channel length. In the embodiment shown, the first channellength and the second channel lengths are different.

The hub 200 also includes an aperture 210 extending through the lengthof the elongate body 202. The aperture 210 extends along the length ofthe elongate body from the distal end to the proximal end so that afluid, needle, or other component can pass through the elongate body202.

FIGS. 7-8 show a locking ring 300 in accordance with one or moreembodiments of the invention. The locking ring 300 includes a hollowcylindrical body 302 having a proximal end 303 with a proximal face 304and a distal end 305 and distal face 306 defining a locking ring lengthextending along an axis. The hollow cylindrical body 302 has an insidesurface 307 and an outside surface 308.

The locking ring 300 is generally sized to fit within the at least onecircumferential channel 212 in the hub 200 so that the proximal face 304is adjacent the proximal end 214 of the channel 212 and the distal faceis adjacent the distal end 216 of the channel 212 in the hub 200. Thelocking ring 300 can be sized to be rotatably seated within thecircumferential channel 212 of the hub. As used in this specificationand the appended claims, the term “rotatably seated” means that thelocking ring can rotate within the channel so that the locking ring andthe hub remain substantially concentric.

The locking ring 300 includes at least one ring element 310 whichextends outwardly from the outside surface 308 of the hollow cylindricalbody 302. The at least one ring element 310 is used, in conjunction withan activation element on the outer shield, to rotate the locking ring300 within the circumferential channel 212 of the hub. The shape of thering element 310 works cooperatively with the shape of the activationelement. It will be understood by those skilled in the art that theshapes shown for the ring element and activation element are merelyexemplary and that other shapes can also be employed. Suitable shapesinclude those in which a distally directed force exerts a rotationalforce on the locking ring.

In the embodiments shown in FIGS. 7-8, the at least one ring element 310has a proximal end 312 and a distal end 314. A ramped face 316 extendsfrom the proximal end 312 to the distal end 214 of the ring element 310.The ramped face 316 of some embodiments has an axis that is offset fromthe axis of the hollow cylindrical body 302. In one or more embodiment,distally directed force on the ramped face 316 provides an axiallydirected force to rotate the locking ring within the circumferentialchannel 212.

The ring element 310 shown in FIGS. 7-8 is wedge shaped. Stateddifferently, the ring element 310 shown is substantially triangular witha proximal end 312 being narrower than the distal end 314. The proximalend 312 of the ring element 310 is about even with the proximal face 304of the hollow cylindrical body 302 and the distal end 314 of the ringelement 310 is about even with the distal face 306 of the hollowcylindrical body 302. It will be understood by those skilled in the artthat the proximal end 312 of the ring element 310 does not need to beeven with the proximal face 314 and that the distal end 314 of the ringelement 310 does not need to be even with the distal face 316 of thering element 310.

FIGS. 9-11 show additional embodiments of the locking ring 300 withdifferent shaped ring elements 310. FIG. 9 shows a ring element 310 thatis shaped like a beam that has an axis offset from the axis of thehollow cylindrical body 302 of the locking ring 300. The ring element310 of this embodiment, has a proximal end 312 that is not even with theproximal face 304 of the hollow cylindrical body 302 and a distal end314 that is not even with the distal face 306 of the hollow cylindricalbody 302. It can be seen from the shape of the ring element 310, that adistally directed force would exert a rotational force causing thelocking ring 300 to be rotated toward the left side of the Figure.

FIG. 10 shows another embodiment of a locking ring 300 in which the ringelement 310 is football shaped. The ring element 310 here has a proximalend 312 even with the proximal face 304 and a distal end 314 even withthe distal face 306 of the hollow cylindrical body 302. It can be seenfrom the shape of this ring element 10, that a distally directed forcewould exert a rotational force causing the locking ring 300 to berotated toward the right side of the Figure. It will also be understoodby those skilled in the art that the magnitude of the rotational forcetransferred from the distally directed force will vary depending onwhere along the ramped surface 316 the force is applied. Distallydirected force at a steeper sloped region of the ramped surface 316would exert more rotational force than force directed a shallower slopedregion.

FIG. 11 shows another embodiment of a locking ring 300 in which the ringelement 310 is peg-shaped. Here, the ring element 310 has a proximal end312 which is the proximal-most point of the peg and a distal end 314which is the distal-most point of the peg. The peg-shaped ring element310 has more than one ramped surface 316 that can be used to transferdistally directed force into rotational force. In embodiments of thissort, the shape of the cooperating activation element on the outershield will impact the direction of rotation of the locking ring 300.

The number of ring elements 310 can vary depending on, for example, theshape of the hub 200 and outer shield 400. At least one ring element 310is included on the locking ring 300. The embodiment shown in FIGS. 7 and8 have two ring elements 310, but it will be understood by those skilledin the art that any number of ring elements can be incorporated into thelocking ring. For example, if the hub 200 is an elongate decahedron withten longitudinal channels 208, then the locking ring 300 can have up toten ring elements 310, with each of the ring elements 310 aligned with alongitudinal groove 208 on the huh 200. The alignment of the ringelements 310 with the longitudinal grooves 208 will be described infurther detail below. In some embodiments, the locking ring 300 includestwo ring elements 310 positioned on opposite sides of the hollowcylindrical body 302. The spacing of the ring elements 310 about thehollow cylindrical 302 can be distributed in any suitable manner and atany suitable degrees about the locking ring 300. For example, there canbe two ring elements 310 spaced 180° apart, or spaced in the range ofabout 10° to about 170° apart. In another example there are in the rangeof two ring elements to 10 ring elements spaced in the range of about 5°to about 175° apart.

Referring back to FIGS. 7 and 8, the locking ring 300 also includes atleast one locking tab 320 extending outwardly from the outside surface308 of the hollow cylindrical body 302. The locking tab 320 includes aproximal locking face 322 extending a first distance from the outsidesurface 308 of the hollow cylindrical body 302. The locking tab 320 alsoincludes a distal edge 324 extends a second distance from the outsidesurface 308 of the hollow cylindrical body 302. The second distance isless than the first distance so that a ramped face 326 extends along thelength of the hollow cylindrical body 302 from the proximal locking faceto the distal edge.

The first distance that the proximal locking face 322 extends from theoutside surface 308 of the hollow cylindrical body 302 can be anysuitable distance. In some embodiments, the proximal locking face 322extends in the range of about 0.1 mm to about 10 mm from the outsidesurface 308. The proximal locking face 322 can be even with the proximalface 304 of the locking ring 300 or a distance down the outside surface308 from the proximal face 304 so that the proximal locking face 322 isnot even with the proximal face 304.

The second distance that the distal edge 324 of the locking tab 320extends from the outside surface 308 of the hollow cylindrical body 302can vary depending on the desired shape of the locking tab 320. Thesecond distance is in the range of about 0 mm to about 9.9 mm and isless than first distance. In some embodiments, the second distance issubstantially zero. As used in this specification and the appendedclaims, the term “substantially zero” means that distal edge 324 isclose to being even with the outside surface 308 of the locking ring 300and can be, for example, within the range of about 0.1 mm beneath theoutside surface 308 and about 0.1 mm above the outside surface 308 ofthe locking ring 300. The distal edge 324 of the locking tab 320 can beeven with the distal face 306 of the locking ring 300 or a distanceproximally from the distal face 306 of the locking ring 300.

The outside curvature of the ramped face 326 of the at least one lockingtab 320 can vary. The ramped face 326 can be a flat surface, a curvedsurface or any other shaped surface. In some embodiments, the rampedface 326 of the at least one locking tab 320 is curved to be concentricto the hollow cylindrical body 302 of the locking ring 300.

The number of locking tabs 320 can vary depending on, for example, theshape of the hub 200 and outer shield 400. At least one locking tabs 320is included on the locking ring 300. The embodiment shown in FIGS. 7 and8 have two locking tabs 320, but it will be understood by those skilledin the art that any number of locking tabs 320 can be incorporated intothe locking ring 300. For example, if the hub 200 is an elongatedecahedron with ten longitudinal channels 208, then the locking ring 300can have up to ten locking tabs 320, with each of the locking tabs 320aligned with a longitudinal groove 208 on the hub 200. In someembodiments, the locking ring 300 includes two locking tabs 320positioned on opposite sides of the hollow cylindrical body 302. Thespacing of the locking tabs 320 about the hollow cylindrical 302 can bedistributed in any suitable manner and at any suitable degrees about thelocking ring 300. For example, there can be two locking tabs 320 spaced180° apart, or spaced in the range of about 10° to about 170° apart. Inanother example there are in the range of two locking tabs 320 to tenlocking tabs 320 spaced in the range of about 5° to about 175° apart.

In some embodiments, the locking ring 300 includes two ring elements 310on opposite sides of the hollow cylindrical body 300 and two lockingtabs 320 on opposite sides of the hollow cylindrical body 300alternating with the ring elements 310.

Referring to FIGS. 12-14, the assembly includes an outer shield 400comprising an elongate, hollow body 401 having a closed proximal end404, an open distal end 406, an outer surface 402 and an inner surface403. FIG. 12 shows an isometric view of an opaque outer shield 400.FIGS. 13-14 show cross-sectional view of the outer shield 400 shown inFIG. 12 with the inner features visible.

The outer shield 400 includes at least one activation element 410protruding inwardly from the inner surface 403. The at least oneactivation element 410 works cooperatively with the at least one ringelement 310 on the locking ring 300. The cooperative interaction betweenthe activation element 410 and the ring element 310 causes rotation ofthe locking ring 300 within the circumferential channel 212 of the hub.

The at least one activation element 410 can be any suitable shape tointeract the ring element 310. In some embodiments, the activationelement 410 is a substantially triangular wedge with a proximal end 414and distal end 416. The proximal end 414 is wider than the distal end416. A sloped surface 418 extends from the proximal end 414 to thedistal end 416.

The number of activation elements 410 can vary depending on, forexample, the shape of the outer shield 400 and the hub 200. At least oneactivation element 410 is included on the outer shield 400. Theembodiment shown in FIGS. 13 and 14 have two activation elements 410,but it will be understood by those skilled in the art that any number ofactivation elements 410 can be incorporated into the outer shield 400.For example, if the outer shield 400 and hub 200 are elongate decahedronwith ten longitudinal channels 208, then the outer shield 400 can haveup to ten activation elements 410, with each of the activation elements410 aligned with a longitudinal groove 208 on the hub 200. In someembodiments, the outer shield 400 includes two activation elements 410positioned on opposite sides of the outer shield 400. The spacing of theactivation elements 410 can be distributed in any suitable manner and atany suitable degrees about the outer shield 400. For example, there canbe two activation elements 410 spaced 180° apart, or spaced in the rangeof about 10° to about 170° apart. In another example there are in therange of two activation elements 410 to ten activation elements 410spaced in the range of about 5° to about 175° apart.

The outer shield also includes at least one finger 420 biased radiallyinwardly from the body 401. In the embodiments shown in FIGS. 12-14,there are two fingers 420 positioned within an opening 422. The opening422 is an option component and may provide for increased flexing of thefinger 420 distal movement that disables the assembly, as describedfurther below. The fingers 420 can be any suitable shape and are notlimited to those shown in the Figures.

The number of fingers 420 can vary depending on, for example, the shapeof the outer shield 400 and the hub 200. At least one fingers 420 isincluded on the outer shield 400. The embodiment shown in FIGS. 13 and14 have two fingers 420, but it will be understood by those skilled inthe art that any number of fingers 420 can be incorporated into theouter shield 400. For example, if the outer shield 400 and hub 200 areelongate decahedron with ten longitudinal channels 208, then the outershield 400 can have up to ten fingers 420, with each of the fingers 420aligned with a longitudinal groove 208 on the hub 200. In someembodiments, the outer shield 400 includes two fingers 420 positioned onopposite sides of the outer shield 400. The spacing of the fingers 420can be distributed in any suitable manner and at any suitable degreesabout the outer shield 400. For example, there can be two fingers 420spaced 180° apart, or spaced in the range of about 10° to about 170°apart. In another example there are in the range of two fingers 420 toten fingers 420 spaced in the range of about 5° to about 175° apart.

Some embodiment of the outer shield further comprise an aperture 430 onthe closed proximal end 404. The aperture 430 can permit a needle orother device to extend therethrough.

Referring back to FIGS. 1 and 2, some embodiments of the assemblyinclude a spring element 500 which causes the outer shield 400 to slideproximally with respect to the hub 200. A spring element 500 is notlimited to springs, but is any component with a spring constant capableof causing the desired relative movement. In some embodiments the springelement 500 is a spring which contacts the proximal end 204 of the hub200 and the inside of the closed proximal end 404 of the outer shield400. The spring element 500 compresses with manual force to allow theproximal end 204 of the hub 200 to travel slidably with in the outershield 400 toward the closed proximal end 404 of the outer shield.Suitable spring elements include, but are not limited to, springs,foams, plastic, and rubber components with a suitable spring constant.The spring element 500 can be any suitable shape including, but notlimited to helical or leaf shaped elements. Springs in any form ormaterial may be used in addition to compressible solid bodies (i.e.foams) to achieve proximal axial movement of the outer shield relativeto the hub.

The assembly further comprises a needle 600. The needle can bepositioned to extend from the proximal end 404 of the outer shield 400or from the distal end 206 of the hub 200 upon compression of the springelement 500. In some embodiments, the needle 600 extends from theproximal end 204 of the hub 200 within the spring element 500 and theouter shield 400 such that proximal movement of the hub 200 with respectto the outer shield 400 compresses the spring element 500 and causes theneedle 600 to project through the aperture 430 in the outer shield 400.The needle 600 can be affixed to the proximal end 204 of the hub so thatthe relative movement of the outer shield 400 with respect to the hub200 causes the tip 602 of the needle to extend through the aperture 430.The needle 600 is hollow to allow passage of a substance through theneedle and can be in fluid communication with the aperture 210 in thehub 200 to allow passage of a fluid through the hub and the needle. Inone or more embodiments, the hub further comprises a Luer connector 218on the proximal end 20. The Luer connector 218 can be a Luer slip orLuer lock connenctor.

In some embodiments, the needle 600 is positioned within the hub 200 sothat distal movement of the outer shield 400 with respect to the hub 200compresses the spring element 500 and causes the needle 600 to extendfrom the distal end 206 of the hub 200. In embodiments, of the thissort, the needle 500 can be connected to the outer shield 400 so thatthe needle tip 602 remains a fixed distance the connection point to theouter shield. The needle 600 may be any length suitable for hypodermicinjections. The needle 600 is hollow to allow passage of a fluid throughthe needle. In one or more embodiments, the outer shield 400 furthercomprises a Luer connector on the proximal end 404 of the outer shield400.

Referring to FIGS. 15-18, the use of the assembly of some embodiments isdescribed. These Figures show expanded views of the proximal end 204 ofthe hub 200, the distal end 406 of the outer shield 400 and the lockingring 300. FIG. 15 shows the assembly in the unlocked state where distalmovement of the outer shield 400 with respect to the hub 200 ispossible. It can be seen from FIG. 15 that in this initial state, thering element 310 is aligned with a longitudinal groove 208 on the hub.The activation element 410 on the outer shield 400 is also alignedwithin the longitudinal groove 208. The finger 420 is aligned within asecond longitudinal groove 208 and the locking tab 320 is not alignedwith the longitudinal groove 208. This alignment allows the finger 420to pass the locking tab 320 without interference.

From this position, the outer shield 400 is moved distally to the pointshown in FIG. 16. Here, the activation element 410 has made contact withthe ring element 310 and the end of the finger 420 has distally passedthe locking ring 300. The spring element 500 has started to becomecompressed and the needle tip is traveling, relatively, toward eitherthe proximal end of the outer shield 400 or the distal end of the hub200.

Further distal movement of the outer shield 400 with respect to the hub200 causes the activation element 410 to apply distally directed androtation force to the ring element 310. This rotational force causes thelocking ring 300 to rotate until the activation element 410 hascompletely passed the ring element 310. This can be seen in FIG. 17where the activation element 410 is now located distally of the lockingring. The rotation of the locking ring 300 results in the locking tab320 being rotated from out of alignment with the finger 420 andlongitudinal groove 208, to being aligned with the finger 420 andlongitudinal groove 208 so that the ramped surface 326 is in the returnpath of the finger 420.

Cessation of distally directed force on the outer shield 400, orproximal movement of the outer shield 400 with respect to the hub 200(e.g., after injection) results in a locked assembly. FIG. 18 shows thefinal locked state of the assembly. The proximal movement of the outershield 400 causes the at least one finger 420 to ride up the rampedsurface 326 and engage the proximal facing edge 326 preventing furtherrelative movement of the outer shield 400 and hub 200. It can be seenfrom FIG. 18, that further relative movement of the outer shield 400proximally is prevented by the interaction of the activation element 410with the end of the longitudinal groove 208. However, this can also beaccomplished by the finger 420 becoming entrapped between the proximalfacing edge 326 and an end of the longitudinal groove 208.

In some embodiments, the locking ring 300 includes at least oneprojection 340 from one or more of the proximal face 304 and the distalface 306. The at least one projection 340 can cooperatively interactwith at least one complementary recess 220 in the hub 200. In one ormore embodiments, the projection 340 extends proximally from theproximal face 304 of the hollow cylindrical body 302. In someembodiments, the projection 340 extends distally from the distal face306 of the hollow cylindrical body 302. The number of projections 340can vary depending on a variety of factors.

FIGS. 19-25 show some embodiments of projections 340 and recesses 220that may be employed. Each of the Figures shows a portion of a hub 200with a locking ring 300. For clarity, only one ring element 310 is shownon the locking ring 300 and no locking tabs 320 are shown. Additionally,for clarity, a single longitudinal groove 208 is shown for each of thehubs 200. The embodiment shown in FIG. 12 shows a locking ring 300 witha square-shaped projection 340 that is engaged with a square-shapedrecess on the hub 200. The ring element 310 is not aligned with thelongitudinal groove 208, indicating that the locking ring 300 is in thelocked position. The projection 340 extends from the proximal face 304of the locking ring 300 and is engaged with a recess 220 located on theproximal end 214 of the circumferential channel 212.

FIG. 20 shows an embodiment in which there are two arc-shapedprojections 220 on the locking ring 300. A first projection 340 extendsproximally from the proximal face 304 of the locking ring 300 and isengaged with a first recess 220 located on the proximal end 214 of thecircumferential channel 212. A second projection 340 extends distallyfrom the distal face 306 of the locking ring 300 and is engaged with asecond recess 220 located on the distal end 216 of the circumferentialchannel 212. The ring element 310 is shown not aligned with thelongitudinal groove 208 indicating that the locking ring 300 is in thelocked position. In the unlocked position, the projections 340 arefriction fit within the circumferential channel 212 but are not engagedwith the recesses 220. Rotation of the locking ring 300 to the lockedposition moves the ring element 310 to be out of alignment with thelongitudinal groove 208 and the projections 340 engage the recesses 220to prevent, or help prevent, further rotation of the locking ring 300within the recess.

FIG. 21 shows another embodiment of the locking ring 300 and hub 200 inwhich there are two projections 340 and two recesses 220. Only one ofthe projections 340 engage a recess 220 in the unlocked position andonly one projection 340 engages a recess 220 when the locking ring 300is in the locked position. FIG. 21 shows the locking ring 300 in theunlocked position because the ring element 310 is aligned with thelongitudinal groove 208. Embodiments of this sort help prevent thelocking ring 300 from spontaneous rotation because there is aprojection/recess interaction in both the unlocked and locked positions.

The shape of the projection 340 and recess 220 can be any suitable shapeincluding, but not limited to, square, rectangular, trapezoidal,triangular, arc-shaped and finger-like. The embodiment shown in FIG. 19has a rectangular projection 340 and a matching rectangular recess 220.The embodiment shown in FIGS. 20-21 have arc-shaped projections 340 andarc-shaped recesses 220. It will be understood that the shape of theprojection 340 does not need to be the same as the shape of the recess220 so long as the projections 340 and recess 220 can act cooperativelyto mitigate the chance of spontaneous rotation of the locking ring 300.

FIG. 22 shows another embodiment of the locking ring 300 and hub 200 inwhich there is one projection 340 on the proximal face 304 of thelocking ring 300 in a triangle shape with a matching recess 220 on theproximal end 214 of the circumferential channel 212. This embodimentshows an alternate projection and recess combination. A projection 222on the distal end 216 of the circumferential channel 212 cooperates witha recess 342 on the locking ring 300.

FIG. 23 shows an embodiment of the locking ring 300 and hub 200 in whichthere is one projection 340 on the distal face of the locking ring 300and two recesses 220 on the distal end 216 of the circumferentialchannel 212. The Figure shows the locking ring 300 in the lockedposition with the ring element 310 not aligned with the longitudinalgroove 208.

FIGS. 24-25 show a single embodiment in the unlocked and lockedpositions. In FIG. 24, the locking ring 300 is in the unlocked positionwith the ring element 340 in alignment with the longitudinal groove 208.The locking ring 300 and projection 340 are friction fit within thecircumferential channel 300 so that there is a decreased possibility ofspontaneous rotation. Upon activation of the ring element 310, the ringrotates toward the left so that the ring element 310 is no longeraligned with the longitudinal groove 208 and the projection 340 engagesthe recess 220 to reach the locked position with the projection 340 inthe recess 220 as shown in FIG. 25.

Referring back to FIGS. 7 and 8, some embodiments of the locking ring300 includes an opening 350 extending from the proximal face 304 to thedistal face 306 and through the thickness of the hollow cylindrical body302. In one or more embodiments, the opening 350 is wider at the outsidesurface 308 than at the inside surface 307. In some embodiments, atleast one projection 340 is posited to extend one or more of proximallyform the proximal face 304 or distally from the distal face 306 adjacentthe opening 350. In one or more embodiments, there is a recess on thelocking ring 300 adjacent the opening 350.

Each component of the assembly can be made from any suitable materials.For example, the components can be plastic, glass, metal and rubber. Theneedle can be any suitable device and is not strictly limited toneedles. Suitable needs include, but are not limited to, stainless steelneedles, metallic needles, plastic needles and glass needles. The springelement can be made from any suitable materials and is not limited tosprings. The spring element can also be any suitable shape including,but not limited to helical, coiled and leaf shapes. Some embodiments,one or more of the hub 200, locking ring 300, outer shield 400, springelement 500 and needle 600 are made from a material comprisingpolypropylene. The components can be made from transparent, translucentor opaque materials. In some embodiments, the outer shield 400 is madefrom a transparent material so that the needle can be observedthroughout use.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A passively activated safety needle assemblycomprising: a hub having an elongate cylindrical body with an outersurface, a distal end and a proximal end defining a length, an apertureextending through the length of the hub, at least two longitudinalgrooves extending at least partially along the length of the hub, and acircumferential channel; a locking ring having a cylindrical bodyrotatably positioned in the circumferential channel and coaxial with thehub, the locking ring including at least one ring element extendingoutwardly from an outside surface of the locking ring, the at least onering element having a proximal end, a distal end and a ramped faceextending from the proximal end to the distal end, and at least oneramp-shaped locking tab extending outwardly from the outside surface ofthe locking ring, the at least one locking tab having a proximal lockingface extending from the outside surface of the cylindrical body; anouter shield coaxial to and slidable around the hub and locking ring,the outer shield including an elongate hollow cylindrical body with anopen distal end and a closed proximal end with an aperture to permit aneedle to move therethrough, at least one activation element projectinginwardly from an interior surface of the outer shield that engages theat least one ring element, the at least one activation element sized toslidably move within a longitudinal groove on the hub and having a shapethat cooperatively interacts with the at least one ring element on thelocking ring, and at least one finger projecting inwardly from the outershield and sized to slidably move within a longitudinal groove on thehub; a spring element positioned adjacent the proximal end of the hubwithin the outer shield; and a needle extending from the proximal end ofthe hub within the outer shield and the spring element, whereinproximally directed force on the hub causes compression of the springelement, extends a tip of the needle through the aperture in the outershield, and causes the activation element to exert distally directedforce onto the ring element to rotate the locking ring such that the atleast one finger on the outer shield aligns with the at least one rampedsurface.
 2. The assembly of claim 1, wherein subsequent release of theproximally directed force allows the spring element to expand causingdistal movement of the hub with respect to the outer shield so that theat least one finger slides over the at least one ramped surface and thatadditional proximal movement of the hub is prevented by interaction ofthe at least one finger with the proximal locking face.
 3. A passivelyactivated safety needle assembly comprising: an elongate, hollow outershield having a distal end, a proximal end, an outer surface and aninner surface, an activation element protruding inwardly from the innersurface, and at least one finger biased radially inwardly; an elongatehub having a distal end and a proximal end, the hub slidably engagedwith the outer shield and biased to move in proximal direction, the hubincluding a longitudinal groove that guides the activation elementduring relative sliding motion between the hub and the outer shield; aspring element positioned within the elongate, hollow outer shieldadjacent the proximal end of the elongate hub a locking ring on the hubhaving a ring element complementary to the activation element and atleast one ramped surface radially spaced from the ring element andproviding a proximal facing edge, wherein distal movement of the outershield with respect to the hub causes the activation element and ringelement to rotate the locking ring such that the at least one fingeraligns with the ramped surface and subsequent proximal movement of theouter shield causes the at least one finger to engage the proximalfacing edge, preventing further relative movement of the outer shieldand hub.
 4. The assembly of claim 3, wherein the hub includes acircumferential channel and the locking ring is rotatably seated withinthe circumferential channel.
 5. The assembly of claim 3, wherein thering element is a substantially triangular wedge with a proximal end anda distal end, the proximal end being narrower than the distal end. 6.The assembly of claim 3, wherein the activation element is asubstantially triangular wedge with a proximal end and distal end, theproximal end being wider than the distal end.
 7. The assembly of claim3, wherein there are two activation elements.
 8. The assembly of claim3, wherein the locking ring further comprises a longitudinal opening. 9.The assembly of claim 3, further comprising a needle positioned withinthe hub so that distal movement of the outer shield with respect to thehub compresses the spring element and causes the needle to extend fromthe distal end of the hub.
 10. The assembly of claim 3, wherein theactivation element is a substantially triangular wedge with a proximalend and distal end narrower than the proximal end and the ring elementif a complementary triangular wedge with a proximal end and distal endwider than the proximal end.
 11. The assembly of claim 10, wherein theactivation elements are positioned on opposite sides of the outershield.
 12. The assembly of claim 3, wherein there are two ringelements.
 13. The assembly of claim 12, wherein the ring elements are onopposite sides of the locking ring.
 14. The assembly of claim 3, whereinthe locking ring further comprises a projection extending one or more ofproximally and distally from the locking ring.
 15. The assembly of claim14, wherein the elongate hub further comprises at least onecomplementary recess that engages the projection.
 16. The assembly ofclaim 3, wherein the elongate, hollow outer shield further comprises anaperture that permits a needle to extend therethrough.
 17. The assemblyof claim 16, further comprising a needle extending from the proximal endof the elongate hub within the spring element and the outer shield suchthat proximal movement of the hub with respect to the outer shieldcompresses the spring element and causes the needle to project throughthe aperture.
 18. The assembly of claim 17, wherein the needle isconnected to the elongate hub using a Luer connector on the proximal endof the elongate hub.
 19. A safety needle assembly comprising: anelongate cylindrical body having an outer surface, an inner surface, anda length, an aperture extending through the length of the elongatecylindrical body and a longitudinal groove extending at least partiallyalong the length of the elongate cylindrical body; a ring-basedcomponent having a hollow cylindrical body positioned and coaxial withrespect to the elongate cylindrical body; an outer shield coaxial to andslidable with respect to the elongate cylindrical body and thering-based component, the outer shield including an elongate hollowcylindrical body with an open end to permit a needle to movetherethrough; the outer shield having an activation element that engagesthe ring-based component; a spring element positioned within the outershield; and a needle extending within the outer shield and the springelement, the needle having a tip, wherein an axially-directed forcecauses compression of the spring element, causing the outer shield totravel freely, and subsequent release of the axially-directed forceallows the spring element to expand, causing the outer shield toretract, providing protection against needle stick injuries, and whereinthe axially directed force causes the ring-based component and the outershield to rotate with respect to each other, the ring-based componenthas a ring element, wherein the activation element and the ring elementengage each other, the ring element extends outwardly from thering-based component, and the ring element has a ramped surface that cantransfer axially directed force into rotational force and wherein thering-based component further comprises an outwardly extending tab whichmoves in the longitudinal groove upon axial movement of the outershield.
 20. The safety needle assembly of claim 19, wherein theactivation element has a shape and the ring element has a shape suchthat the activation element and the ring element work cooperatively. 21.The safety needle assembly of claim 20, wherein the elongate cylindricalbody has a channel, and the ring-based component fits within thechannel.
 22. The safety needle assembly of claim 19, wherein the ringelement is peg-shaped.
 23. The safety needle assembly of claim 19,wherein axial movement of the outer shield with respect to the elongatecylindrical body causes the activation element and the ring element toengage.
 24. The safety needle assembly of claim 19, wherein cessation ofaxially directed force on the outer shield results in the assembly beinglocked.
 25. The safety needle assembly of claim 24, wherein cessation ofaxially directed force on the outer shield prevents further relativemovement of the outer shield and the elongate cylindrical body.
 26. Asafety needle assembly comprising: an elongate cylindrical body havingan outer surface, an inner surface, and a length, an aperture extendingthrough the length of the elongate cylindrical body and at least twolongitudinal grooves extending at least partially along the length ofthe elongate cylindrical body; a hollow cylindrical body positioned andcoaxial with respect to the elongate cylindrical body; an outer shieldcoaxial to and slidable with respect to the elongate cylindrical bodyand the hollow cylindrical body, the outer shield including an elongatehollow cylindrical body with an open end to permit a needle to movetherethrough; the outer shield having an activation element that engagesthe hollow cylindrical body; a spring element positioned within theouter shield; and a ring-based component having a ring element, whereinthe ring element extends outwardly from the hollow cylindrical body andthe ring element has ramped surface that transfers axially directedforce into rotational force, wherein the outwardly extending tab movesin one of the at least two longitudinal grooves upon axial movement ofthe outer shield; and a needle extending within the outer shield and thespring element, the needle having a tip, wherein an axially-directedforce causes compression of the spring element, causing the outer shieldto travel freely, and subsequent cessation of the axially-directed forceallows the spring element to expand, causing the outer shield toretract, resulting in the assembly being locked.
 27. The safety needleassembly of claim 26, wherein cessation of axially directed force on theouter shield prevents further relative movement of the outer shield andthe elongate cylindrical body.
 28. The safety needle assembly of claim26, the outer shield further comprising an activation element and thehollow cylindrical body, wherein the activation element and the ringelement can engage each other.
 29. The safety needle assembly of claim26, wherein the ring element is peg-shaped.
 30. The safety needleassembly of claim 29, wherein the hollow cylindrical body furthercomprises an outwardly extending tab.
 31. The safety needle assembly ofclaim 30, wherein the outwardly extending tab can move in one of the atleast two longitudinal grooves upon axial movement of the outer shield.